Agnostic Therapy in Rare Solid Tumors
- Registration Number
- NCT06638931
- Lead Sponsor
- Instituto do Cancer do Estado de São Paulo
- Brief Summary
The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.
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- Detailed Description
The ANTARES study is a phase II "basket" trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors. A "basket" trial is an innovative type of clinical trial where patients with different types of cancers, but sharing a common molecular feature (in this case, PD-...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-Arm Efficacy Study Nivolumab Treatment will be administered with intravenous nivolumab at a dose of 480 mg every 4 weeks. Treatment will continue until limiting toxicity, disease progression, or for a maximum of 12 months as maintenance if the individual achieves stable disease, partial response, or complete response.
- Primary Outcome Measures
Name Time Method Primary Objective 2 years Overall survival (in months) of patients with advanced or metastatic rare malignancies and CPS ≥ 10 following disease progression after prior treatments while receiving the anti-PD1 antibody Nivolumab.
Primary Endpoint 2 years The primary outcome of the study is the disease control rate (DCR) based on imaging, considering the best response to treatment. A response rate of 5% will be considered non-promising, and a response rate of 25% will be considered promising. The study follows Simon's two-stage design, with type I error (alpha) set at 0.05 and type II error (beta) at 0.10. In...
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 2 years Percentage of patients with a tumor size reduction, measured according to RECIST criteria.
Subgroup Analysis Based on PD-L1 Expression and CPS: 2 years PD-L1 Expression: Proportion of patients showing PD-L1 positivity. CPS Subgroups: Proportion of patients with CPS between 10-20 and those with CPS \> 20.
Correlation of Clinical Outcomes with Biomarker Assessments 2 years Microvesicle Analysis: Correlation between clinical outcomes and levels of circulating microvesicles.
Serum Multiplex Panel: Correlation between clinical outcomes and serum biomarker levels (e.g., cytokines, chemokines), measured in concentration units (e.g., pg/mL).Overall Survival (OS) 2 years Time from treatment initiation to death from any cause, measured in months.
Progression-Free Survival (PFS) 2 years Time from treatment initiation to disease progression or death, whichever occurs first, measured in months.
Trial Locations
- Locations (8)
Hospital São Rafael
🇧🇷Salvador, Bahia, Brazil
Hospital São Carlos
🇧🇷Fortaleza, Ceará, Brazil
Hospital Santa Cruz
🇧🇷Curitiba, Paraná, Brazil
IDOR Recife
🇧🇷Recife, Pernambuco, Brazil
Instituto D'or de Pesquisa e Ensino
🇧🇷Sao Paulo, SP, Brazil
Instituto do Câncer do Estado de São Paulo - ICESP
🇧🇷São Paulo, SP, Brazil
DF Star
🇧🇷Brasília, Brazil
Instituto D'Or de Pesquisa e Ensino
🇧🇷Rio De Janeiro, Brazil